MAUDE Adverse Event Report: CONMED CORPORATION PAD PRO RADIOTRANSPARENT ELECTRODE DEFIB HANDOFF PAD; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 2001Z

Device Problem Defective Device (2588)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 10/30/2018

Event Type  Injury  

Event Description

Pt undergoing cardioversion using pad pro device.When sync.Cv at 200 joules was delivered an electric arc was noted.Pt was burned.Skin observed with second - third-degree burns at perimeter of pad.Pt had no other outcomes topical silverdine lotion prescribed for application to burn.

• Brand Name: PAD PRO RADIOTRANSPARENT ELECTRODE DEFIB HANDOFF PAD
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502 5994
• MDR Report Key: 8056044
• MDR Text Key: 126705090
• Report Number: MW5081170
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2020
• Device Model Number: 2001Z
• Device Lot Number: Y12121708
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR